CN106860420A - A kind of production technology of hydroxypropul starch Capsules - Google Patents
A kind of production technology of hydroxypropul starch Capsules Download PDFInfo
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- CN106860420A CN106860420A CN201510908460.9A CN201510908460A CN106860420A CN 106860420 A CN106860420 A CN 106860420A CN 201510908460 A CN201510908460 A CN 201510908460A CN 106860420 A CN106860420 A CN 106860420A
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- room temperature
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4816—Wall or shell material
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Abstract
The present invention relates to a kind of production technology of hydroxypropul starch Capsules, the production technology is by gel hydroxypropyl starch, carragheen, maltodextrin, glycerine, potassium chloride, purified water, by weigh dispensing, colloidal sol, be incubated, dip in gum forming, dry the processes such as the demoulding, otch, fit, inspection, packed products complete, presently disclosed production technology is compared with other techniques, it is high with technological level, fully, the hydroxypropul starch Capsules according to obtained by this kind of technique can be used in medicine, food and health product capsule agent material process.
Description
Technical field
The present invention relates to a kind of production technology of hydroxypropul starch Capsules, belong to medicine manufacture field.
Background technology
Capsule is not only widely used in medicine manufacture, together as one of current most popular formulation
When most of health food also use this one dosage type low temperature, be such as filled with and the soft capsule of cod-liver oil and be filled with
Hard shell capsules of natural plant extracts etc..
The development process of capsule has prescription research and development simple compared to tablet exploitation, the technical study time
It is short, the fast advantage of the achievement speed of response.Because capsule is different from tablet, the gustatory receptor of user will not
Medicine is directly contacted, therefore is not required to consider the selection of flavouring or odor mask；Meanwhile, capsule is filled out
Fill very simple with production technology, it is only necessary to be filled into medicine compressing in softgel shell, be not required to carry out
Similar to the preparation prescription research of tablet, research work amount is greatly reduced, accelerate research and development process and product
Product list speed.
It is gelatin that the industry of capsule for medicine manufactures the most frequently used raw material, this be due to it have gelling, into
The characteristic of the aspect such as film and surface-active.Given full play to using proofing method of molding manufacture hard gelatin capsule
Its gelling and film forming ability.The manufacturing process of this kind of hard shell capsules includes, by mold pin proofing gelatin heat
In solution, mould pin is taken out from gelatin solution, allows the gelatin solution sticked on mould pin to solidify by cooling,
Dry and the shell being thusly-formed of being backed off from mould pin.
System of Himdu logic glue is animal origin, there is security risk, is also not suitable for Islam and kosher faith
Person uses, and is influenceed by " rabid ox disease " and " toxic capsule " event in addition, has more aggravated the common people to gelatin
The distrust of capsule, the correlative study for preparing capsule using non-gelatin materials in recent years is risen, it is intended to avoided
Ruan Shi body-sensings contaminate and do not use the gelatin of animal sources.Such capsule has abandoned the gelatin of animal sources, excavates
Natural plants capsule material, such as polysaccharide, natural plant gum, converted starch, substituted cellulose.Particularly
Capsule is usually manufactured with modified fibre, many trials had been done.Successfully industry example is by hydroxypropyl first
The capsule of base cellulose (HPMC) manufacture, HPMC capsules show some excellent better than gelatin hollow capsule
Point.However, raw material HPMC is much more expensive compared with gelatin.
Starch is another abundant natural polysaccharide, its renewable, biodegradable and low cost.But
Because its film forming is limited and mechanical performance is bad, viscosity or hardness are difficult to meet wanting for production capsule
Ask, while the easily moisture absorption, the requirement of capsule preservation condition is higher, and the shelf-life is not long, therefore in this field
Success be restricted.Unique industry example (Us4,738,724) is the starch by being molded production
Capsule, but the special mold filling of the much bigger and different shape need of thickness and mold closing of this kind of capsule set
It is standby.
This problem is solved at present, is mostly the material based on starch material, by adding other materials,
Improve the mechanical performance of integral material, be allowed to match the demand of capsule preparation.It is common for add polysaccharide and
Natural plant gum, such as carragheen, xanthans, gum gellan, guar gum, furcellaran, in addition auxiliary plasticising
Agent, adhesive and gel, prepare capsule.
But at present, there is not yet starch hollow capsule launch.It is primarily due to made finished product
Quality is not sufficiently stable, and gelatine capsule can not be completely matched in performance.Therefore it provides a kind of production is with starch
The production technology of the starch capsule of material based on material, is the major issue for needing to solve at present.
The content of the invention
The invention provides a kind of technique of the hydroxypropul starch Capsules for solving above-mentioned technical problem, tool
Body is as follows：
Step 1) weigh dispensing；
Step 2) colloidal sol, insulation froth breaking：By the gel hydroxypropyl starch of formula ratio, carragheen, sweet
Oil, maltodextrin, potassium chloride order are poured into the pure water of formula ratio, are stirred, and chuck water-bath adds
Heat is to 70 ± 5 DEG C, and constant temperature stirring 60-90min, is allowed to dissolve into uniform glue；By glue temperature
57 ± 2 DEG C are reduced to, constant temperature stands 130-150 minutes, remove glue bubble；
Step 3) mould and dip in gum forming：The water-bath of glue groove chuck is circulated, and it is 57 ± 2 DEG C to control glue temperature
Dip in glue molding；
Step 4) dry the demoulding：Capsules A, B capillus bases, blank under sizing ingot stripper copper sheathing clamp removing
Water content 9-13%；
Step 5) otch：Demoulding blank capsule opener is cut into the length of regulation, otch is smooth；
Step 6) fit：By Capsules A, B the assembling machine fit after otch；
Step 7) check and packaging.
Wherein, in step 3) in, environmental Kuznets Curves are：D grades of clean area, room temperature controls 23 DEG C -25 DEG C；
Relative humidity 53%-55%；
In step 4) in, environmental Kuznets Curves are：D grades of clean area, 21-23 DEG C of room temperature；Hot-air 29-33
DEG C, flow velocity 0.55-0.75m/s, 60-70min；Relative humidity 55%-75%；
In step 5) in, environmental Kuznets Curves are：D grades of clean area, room temperature controls 23 DEG C -25 DEG C；Relatively
Humidity 53%-55%
In step 6) in, environmental Kuznets Curves are：D grades of clean area, room temperature controls 20 DEG C -23 DEG C；Relatively
Humidity 55%-75%.
In wherein, it is characterised in that in step 3), environmental Kuznets Curves are：D grades of clean area, room temperature control
22 DEG C of system；Relative humidity 55%；
In step 4) in, environmental Kuznets Curves are：D grades of clean area, 22 DEG C of room temperature；30 DEG C of hot-air,
Flow velocity 0.6m/s, 60min；Relative humidity 55%；
In step 5) in, environmental Kuznets Curves are：D grades of clean area, room temperature controls 24 DEG C；Relative humidity
55%
In step 6) in, environmental Kuznets Curves are：D grades of clean area, room temperature controls 22 DEG C；Relative humidity
70%.
Wherein, the dispensing is configured in the following manner：
Gel hydroxypropyl starch 900g-1200g
Carragheen 80-200g
Maltodextrin 200g-300g
Glycerine 30-80g
Potassium chloride 1-9g
Purified water 2500-5500g.
We study by starch and modified starch materials, have been surprisingly found that and formed sediment using hydroxypropyl
Powder, especially hydroxypropyl content gel hydroxypropyl starch within the specific limits, through weighing dispensing,
Colloidal sol, insulation, are adding a small amount of hydrophilic gel carragheen, maltodextrin and plasticizer glycerine, glue
Solidifying agent potassium chloride can be prepared into Capsules, and the stability of the capsule is high, and performance is higher than gelatine capsule.
Brief description of the drawings
The accompanying drawing for being incorporated into specification and constituting a part for specification shows implementation of the invention
Example, and be used to explain principle of the invention together with the description.In the drawings, similar accompanying drawing mark
Remember for representing similar key element.Drawings in the following description are some embodiments of the present invention, rather than
Whole embodiments.For those of ordinary skill in the art, on the premise of not paying creative work,
Other accompanying drawings can be obtained according to these accompanying drawings.
Fig. 1 illustrates the production technological process of hydroxypropul starch Capsules provided by the present invention.
Specific embodiment
To make the purpose, technical scheme and advantage of the embodiment of the present invention clearer, below will be to the present invention
Technical scheme in embodiment is clearly and completely described, it is clear that described embodiment is this hair
Bright a part of embodiment, rather than whole embodiments.Based on the embodiment in the present invention, this area is general
The every other embodiment that logical technical staff is obtained under the premise of creative work is not made, belongs to
The scope of protection of the invention.It should be noted that in the case where not conflicting, the embodiment in the application
And the feature in embodiment can mutually be combined.
Basic thought of the invention is to be equipped with other auxiliary materials by using gel hydroxypropyl starch, via
Certain technical process forms the production technology of hydroxypropul starch Capsules.Demonstrate,proved via substantial amounts of experiment
It is bright, hydroxypropyl content gel hydroxypropyl starch within the specific limits, through weighing dispensing, colloidal sol,
Insulation, is adding a small amount of hydrophilic gel carragheen, maltodextrin and plasticizer glycerine, gelling agent chlorine
Changing potassium can be prepared into Capsules, and its stability is high, be higher than gelatine capsule in performance.
The production technology of hydroxypropul starch Capsules provided by the present invention is：
Step 1) weigh dispensing：Gel hydroxypropyl starch 900g-1200g；Carragheen 80-200g；
Maltodextrin 200g-300g；Glycerine 30-80g；Potassium chloride 1-9g；Purified water 2500-5500g.
Step 2) colloidal sol, insulation froth breaking：By the gel hydroxypropyl starch of formula ratio, carragheen, sweet
Oil, maltodextrin, potassium chloride order are poured into the pure water of formula ratio, are stirred, and chuck water-bath adds
Heat is to 70 ± 5 DEG C, and constant temperature stirring 60-90min, is allowed to dissolve into uniform glue；By glue temperature
57 ± 2 DEG C are reduced to, constant temperature stands 130-150 minutes, remove glue bubble.
Step 3) mould and dip in gum forming：The water-bath of glue groove chuck is circulated, and it is 57 ± 2 DEG C to control glue temperature
Dip in glue molding.Environmental Kuznets Curves：D grades of clean area, 21-23 DEG C of room temperature；Relative humidity 55%-75%.
Step 4) dry the demoulding：Capsules A, B capillus bases, blank under sizing ingot stripper copper sheathing clamp removing
Water content 9-13%.Environmental Kuznets Curves：D grades of clean area, 21-23 DEG C of room temperature；29-33 DEG C of hot-air,
Flow velocity 0.55-0.75m/s, 60-70min；Relative humidity 55%-75%.
Step 5) otch：Demoulding blank capsule opener is cut into the length of regulation, otch is smooth.
Environmental Kuznets Curves：D grades of clean area, room temperature controls 23 DEG C -25 DEG C；Relative humidity 53%-55%.
Step 6) fit：By Capsules A, B the assembling machine fit after otch.Environmental Kuznets Curves：
D grades of clean area, room temperature controls 20 DEG C -23 DEG C；Relative humidity 55%-75%.
Step 7) check and packaging：By Chinese Pharmacopoeia 4 hydroxypropul starch Capsuleses of version in 2015
Standard test.Inspection is qualified, and interior bag, corrugated case outsourcing, bag are counted with low density polyethylene (LDPE) medical bag
Finished product is after dress.
Wherein, in above-mentioned steps 1) in, each dispensing can also prepare according to following contents, pregelatinated
Hydroxypropul starch 1000-1100g；Carragheen 100-150g；Maltodextrin 150-200g；Glycerine 50-70g；
Potassium chloride 5-8g；Purified water 3000-5000g.
Especially, can be 1000g for gel hydroxypropyl starch content；Carragheen content is 100g；
Maltodextrin content is 150g；Glycerol content is 60g；KCE content is 7g；Purifying water content is
3500g。
Or can be：Gel hydroxypropyl starch content is 1100g；Carragheen content is 120g；Wheat
Bud dextrin content is 160g；Glycerol content is 50g；KCE content is 5g；Purifying water content is 3000g.
Other possible embodiments are as follows：
Certainly, above-mentioned batching mode is only exemplary, does not constitute limitation of the invention.In reality
In the application of border, can be determined as needed.
Standard and the method for inspection：
Proterties：This product is cylindrical, be by can the matter that constitutes of fit and sealed cap and the section of body two it is hard and have
The empty pocket of elasticity.Utricule should bright and clean, uniform color, otch it is smooth, without deformation, without foreign odor.This product point
It is transparent (two sections are free of opacifier), translucent (only one section contains opacifier), opaque (two sections
Contain opacifier) three kinds.
Differentiate：(1) this product 0.6g is taken, add water 30ml, is mixed, add iodine test solution 1 to drip immediately, solution
Aobvious blue or reddish violet.
(2) this product 0.2g is taken, in putting 200ml measuring bottles, plus dilute sulfuric acid 13.5ml, heating water bath makes molten
Solution, is cooled to room temperature, is diluted with water to scale, shakes up.Take during 1ml puts tool plug test tube, put cold bath
In, sulfuric acid 9ml is added dropwise over, mix, move to heating water bath 3 minutes, test tube is transferred to ice bath at once
Middle cooling, and put to room temperature, ninhydrin solution 0.7ml is carefully added into along test tube wall, shake up immediately, in
Kept for 100 minutes in 28 DEG C of water-baths.Plus sulfuric acid 16ml, reversing tube several times makes mixing (can not shake).
In 5 minutes aobvious purples of planted agent.
Check：Elasticity, takes this product 10, and capsule two ends are gently pinched with thumb and forefinger, and rotation is pushed aside,
Must not have bonding, deformation or rupture, then fill talcum powder, by cap, body set merge it is sealed, by grain in
It is straight at the height of 1ml to fall in thickness on the plank of 3cm, powder leaked；If any a small amount of leakage powder, must not
More than 2.Such as exceed, should separately take 10 retrials, regulation all should be met.
Friability, takes this product 60, puts in surface plate, is put into the drying for filling saturated solution of magnesium sulfate
In device, 26 DEG C of ± 2 DEG C of constant temperature are put 24 hours, taken out, be put into by grain that to stand upright on plank (thick respectively immediately
Degree 2cm) on glass tube (internal diameter is 25mm, a length of 2600mm) in, by cylindrical counterweight (material
Matter is polytetrafluoroethylene (PTFE), a diameter of 23mm, weight 22g ± 0.2g) freely fallen from the glass mouth of pipe,
Whether ruptured depending on capsule, if any rupture, must not exceed 5.
Disintegration time limited, this product 8 is taken, fill talcum powder, according to disintegration time limited inspection technique (general rule 0921)
Method under capsule, plus baffle plate is checked, should be all disintegrated in 30 minutes.
Loss on drying, takes this product 1.0g, and cap, body is separate, in 130 DEG C of dryings 90 minutes, less loss
Weight must not cross 15.0% (general rule 0831).
Residue on ignition, takes this product 2.0g, checks (general rule 0841) in accordance with the law, and remaining residue must not distinguish
3.0% (transparent), 5.0% (translucent) and 5.0% (opaque).
Heavy metal, takes the residue left under residue on ignition, checks (method of general rule 0,821 second) in accordance with the law,
20/1000000ths must not be crossed containing heavy metal.
Microbial limit, takes this product, is needed in checking (general rule 1105 and general rule 1106) per 1g in accordance with the law
Oxygen bacterium sum must not cross 1000cfu, and yeast and mold sum must not cross 100cfu, must not detect large intestine
Angstrom uncommon bacterium.
Classification：Pharmaceutic adjuvant, for the preparation of capsule.
Storage：It is closed, preserved under the conditions of 10~25 DEG C of temperature, relative humidity 35%~65%.
Finally it should be noted that：Herein, term " including ", "comprising" or its any other
Variant is intended to including for nonexcludability, so that process, method, thing comprising a series of key elements
Product or equipment not only include those key elements, but also other key elements including being not expressly set out, or
It is also to include being this process, method, article or the intrinsic key element of equipment.Without more limitations
In the case of, the key element limited by sentence " including ... ", it is not excluded that including the key element
Also there is other identical element in process, method, article or equipment.
The above embodiments are merely illustrative of the technical solutions of the present invention, rather than its limitations.Although with reference to preceding
Embodiment is stated to be described in detail the present invention, it will be understood by those within the art that：Its
The technical scheme described in foregoing embodiments can still be modified, or to which part technology
Feature carries out equivalent；And these modifications or replacement, do not make the essence disengaging of appropriate technical solution
The spirit and scope of various embodiments of the present invention technical scheme.
Claims (4)
1. a kind of production technology of hydroxypropul starch Capsules, it is characterised in that comprise the following steps：
Step 1) weigh dispensing；
Step 2) colloidal sol, insulation froth breaking：By the gel hydroxypropyl starch of formula ratio, carragheen, sweet
Oil, maltodextrin, potassium chloride order are poured into the pure water of formula ratio, are stirred, and chuck water-bath adds
Heat is to 70 ± 5 DEG C, and constant temperature stirring 60-90min, is allowed to dissolve into uniform glue；By glue temperature
57 ± 2 DEG C are reduced to, constant temperature stands 130-150 minutes, remove glue bubble；
Step 3) mould and dip in gum forming：The water-bath of glue groove chuck is circulated, and it is 57 ± 2 DEG C to control glue temperature
Dip in glue molding；
Step 4) dry the demoulding：Capsules A, B capillus bases, blank under sizing ingot stripper copper sheathing clamp removing
Water content 9-13%；
Step 5) otch：Demoulding blank capsule opener is cut into the length of regulation, otch is smooth；
Step 6) fit：By Capsules A, B the assembling machine fit after otch；
Step 7) check and packaging.
2. the production technology of hydroxypropul starch Capsules as claimed in claim 1, it is characterised in that
In step 3) in, environmental Kuznets Curves are：D grades of clean area, room temperature controls 23 DEG C -25 DEG C；Relative humidity
53%-55%；
In step 4) in, environmental Kuznets Curves are：D grades of clean area, 21-23 DEG C of room temperature；Hot-air 29-33
DEG C, flow velocity 0.55-0.75m/s, 60-70min；Relative humidity 55%-75%；
In step 5) in, environmental Kuznets Curves are：D grades of clean area, room temperature controls 23 DEG C -25 DEG C；Relatively
Humidity 53%-55%
In step 6) in, environmental Kuznets Curves are：D grades of clean area, room temperature controls 20 DEG C -23 DEG C；Relatively
Humidity 55%-75%.
3. the production technology of hydroxypropul starch Capsules as claimed in claim 2, it is characterised in that
In step 3) in, environmental Kuznets Curves are：D grades of clean area, room temperature controls 22 DEG C；Relative humidity 55%；
In step 4) in, environmental Kuznets Curves are：D grades of clean area, 22 DEG C of room temperature；30 DEG C of hot-air,
Flow velocity 0.6m/s, 60min；Relative humidity 55%；
In step 5) in, environmental Kuznets Curves are：D grades of clean area, room temperature controls 24 DEG C；Relative humidity
55%
In step 6) in, environmental Kuznets Curves are：D grades of clean area, room temperature controls 22 DEG C；Relative humidity
70%.
4. the production technology of the hydroxypropul starch Capsules as described in any in claim 1-3, its
It is characterised by, the dispensing is configured in the following manner：
Gel hydroxypropyl starch 900g-1200g
Carragheen 80-200g
Maltodextrin 200g-300g
Glycerine 30-80g
Potassium chloride 1-9g
Purified water 2500-5500g.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510908460.9A CN106860420A (en) | 2015-12-11 | 2015-12-11 | A kind of production technology of hydroxypropul starch Capsules |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510908460.9A CN106860420A (en) | 2015-12-11 | 2015-12-11 | A kind of production technology of hydroxypropul starch Capsules |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106860420A true CN106860420A (en) | 2017-06-20 |
Family
ID=59236578
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510908460.9A Pending CN106860420A (en) | 2015-12-11 | 2015-12-11 | A kind of production technology of hydroxypropul starch Capsules |
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| Country | Link |
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| CN (1) | CN106860420A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108686224A (en) * | 2018-06-26 | 2018-10-23 | 安徽紫山农业科技有限公司 | A kind of hydroxypropul starch Capsules and its preparation process |
| CN111000821A (en) * | 2019-12-30 | 2020-04-14 | 河南新孚望新材料科技有限公司 | Hydroxypropyl starch empty capsule and preparation method thereof |
-
2015
- 2015-12-11 CN CN201510908460.9A patent/CN106860420A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108686224A (en) * | 2018-06-26 | 2018-10-23 | 安徽紫山农业科技有限公司 | A kind of hydroxypropul starch Capsules and its preparation process |
| CN111000821A (en) * | 2019-12-30 | 2020-04-14 | 河南新孚望新材料科技有限公司 | Hydroxypropyl starch empty capsule and preparation method thereof |
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Application publication date: 20170620 |